This is a ready-to-use work instruction for investigator-site staff correcting a source document entry, an electronic health record entry, or a case report form (CRF) field. It sits under the parent SOP <<FILL: source documentation / CRF completion SOP-ID>> and gives the exact steps, per role, for each record type, plus what to do when the correction is triggered by a monitor’s data query. Replace every <<FILL: ...>> placeholder. A filled specimen follows. This is general guidance to adapt and verify, not legal or regulatory advice.
Header
| Field | Entry |
|---|---|
| Work instruction number | <<FILL: WI-ID, e.g. WI-CLIN-014>> |
| Parent SOP | <<FILL: source documentation / CRF completion SOP-ID>> |
| Version / effective date | <<FILL>> |
| Applies to | Investigator, sub-investigator, and delegated site staff (per the delegation of authority log <<FILL: ID>>) who record source data or complete the CRF |
| Study / protocol | <<FILL: protocol number>> |
When to use this work instruction
Use it whenever a source document entry, an EHR entry, or a CRF field needs to be corrected, whether you found the error yourself or a monitor raised a data query about it. Use it also for a legitimate late entry on a source document. Do not use it to alter a source document or CRF after database lock or after the record has otherwise been formally closed; that goes through the amendment or database unlock route in the parent SOP.
Who may make the correction
Only the investigator or a person to whom the task is specifically delegated on the delegation of authority log may correct site source data or the CRF.
A monitor, a sponsor representative, or a CRA who finds a discrepancy during source data verification does not correct it. The monitor’s role stops at raising a data query naming the field and the discrepancy; the site investigates against the source and makes the change. Treat any pressure from outside the site to change a value without your own verification against source as a data integrity concern, and raise it to the investigator and the sponsor’s clinical quality function the same day.
Tools and materials
- The source document, EHR access, or the EDC system, as applicable.
- Approved indelible pen for paper (blue or black; never pencil, never erasable ink).
- Your initials and signature as recorded in the site’s delegation of authority and signature records.
- The query text, if the correction is query-driven.
Task A: correct a paper source document or paper CRF entry
| Step | Action | Acceptance for this step |
|---|---|---|
| A1 | Confirm you are the person who made the original entry, or that you are the delegated person authorized to correct it. | Only an authorized person makes the change. |
| A2 | If the correction responds to a query, re-verify the value against the source before changing anything. | The corrected value traces to a real source, not to the query text alone. |
| A3 | Draw a single straight line through the wrong entry so the original stays fully legible. | The original value can still be read. |
| A4 | Write the correct value next to it, with a clear pointer if space is tight. | The correct value is unambiguous. |
| A5 | Add your initials and the date, and a short reason for the change. | The correction is attributable, dated, and explained. |
| A6 | Never erase, white-out, scribble over, or write over the original. | No obliteration; the first entry remains readable. |
| A7 | If the correction was query-driven, reference the query ID next to the correction or in the query log. | The correction and the query can be matched to each other. |
Task B: correct an entry in an electronic health record used as source
| Step | Action | Acceptance for this step |
|---|---|---|
| B1 | Do not delete or overwrite the original EHR entry. Use the EHR’s own correction, addendum, or amendment function. | The original entry remains visible in the EHR; nothing is silently replaced. |
| B2 | Enter the correct value and a reason using the EHR’s amendment mechanism. | The system captures who made the change, when, and why. |
| B3 | If the EHR cannot be produced directly to the monitor or sponsor, generate or update the certified copy used for monitoring and file review. | The certified copy reflects the corrected entry and is re-certified if the certification method requires it. |
| B4 | Note the correction in the site’s source document if a paper cross-reference exists. | The paper and electronic records stay consistent with each other. |
See the certified copy form if the correction requires a new or updated certified copy.
Task C: correct a CRF field in EDC in response to a data query
| Step | Action | Acceptance for this step |
|---|---|---|
| C1 | Open the query in the EDC system and read exactly what is being asked. | The correction responds to the actual discrepancy, not a guess at it. |
| C2 | Locate and re-check the source document or EHR entry for the field in question. | The corrected value is confirmed against source before anything is typed. |
| C3 | Enter the corrected value directly in the EDC field. | The audit trail captures the original value, the new value, who made the change, and when. |
| C4 | Enter a reason for change that states what was wrong and how the correct value was confirmed, not a single word. | The reason names the cause and the source checked (for example “transcription error, confirmed against Week 4 vitals worksheet”). |
| C5 | Respond to the query in the EDC query text with a short explanation, and mark it answered. | The monitor can see, from the query thread alone, what changed and why. |
| C6 | If the correction reveals a broader problem (a pattern across visits or subjects, a process issue at the site), notify the investigator and the sponsor’s clinical team. | A pattern is escalated, not treated as an isolated fix. |
What to do if a correction changes a safety report or an efficacy endpoint
Stop and notify the investigator the same working day before closing the query. A correction to a reported adverse event, a serious adverse event, or a primary or secondary endpoint value may require a safety report amendment, may affect an ongoing analysis, or may itself be a protocol deviation depending on cause. Route it through <<FILL: safety reporting / protocol deviation SOP-ID>> in addition to closing the query.
Acceptance criteria
- The correction was made only by the investigator or a delegated, authorized person, never by the sponsor or monitor.
- The corrected value was verified against source before being entered.
- The original entry remains legible or is retained in the audit trail; nothing was obliterated or silently overwritten.
- The correction carries initials or system attribution, a date or timestamp, and a specific reason.
- A query-driven correction is linked to its query and the query is closed only after the correction is confirmed.
- A correction affecting safety data or an endpoint was escalated per the safety reporting or deviation procedure.
References
ICH E6(R2) section 4.9.3 (CRF corrections, dated, initialed, explained, without obscuring the original) and section 5.18.4 (monitor verification against source). FDA guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (final, announced October 2024). 21 CFR Part 11 (audit trails, electronic records and signatures). Good documentation practices for the paper correction convention: see Good Documentation Practices.
Confirm the current version of each reference before issue.
Filled specimen
Task C, a query-driven CRF correction:
| Field | Entry |
|---|---|
| Query ID | Q-0123-014 |
| Query text | Week 4 systolic BP eCRF value 138 mmHg does not match source worksheet value 158 mmHg. Please verify and correct. |
| Source checked | Week 4 vital signs worksheet, dated and initialed by the site nurse |
| Corrected value | 158 mmHg |
| Reason for change | Transcription error at CRF entry; confirmed against Week 4 vitals worksheet |
| Entered by | Site coordinator, EDC login, timestamped |
| Original value in audit trail | 138 mmHg, retained |
| Query response | ”Confirmed source value 158 mmHg; eCRF corrected, reason for change entered.” |
| Query status | Closed after monitor confirmation at next SDV |
The audit trail shows both values, who changed the field, when, and why. The query thread shows what was asked and how it was resolved. Nobody outside the site made the change, and a reviewer or inspector can reconstruct the whole event from the two records together.
Common mistakes this work instruction prevents
- A monitor or sponsor representative correcting site data directly instead of raising a query.
- A CRF field corrected with a one-word or blank reason for change, so a reviewer cannot tell why the value changed.
- An EHR entry overwritten instead of amended, destroying the original.
- A query closed on a verbal assurance instead of a confirmed, documented correction.
- A correction to safety or endpoint data made and closed without escalation to the investigator.
How to adapt this work instruction
- Set the WI number and point the parent-SOP field at your real source documentation or CRF completion procedure.
- Confirm your EDC system’s audit trail and reason-for-change field configuration match steps C3 to C5.
- Point the safety reporting and deviation cross-references at your real procedures.
- Pair this work instruction with the SDV discrepancy and data query log so every query-driven correction is tracked end to end.